Print date: 2015-12-07
Regulatory Information
Potassium carbonate and solutions
CAS Name: Carbonic acid, potassium salt (1:2) / CAS-No.: 584-08-7
1.
REACH
1.1
EU-REACH
For the product purchased from or imported by Evonik Performance Materials GmbH,
Germany we certify that these products are in compliance with REACH.
The substance in this product is registered. The REACH registration number and the
identified safe uses are communicated in the Safety Data Sheets only on EC member states
level. This substance is classified as hazardous, meaning that exposure assessment is
required for this substance. Please refer to the extended Safety Data Sheet
1.2
EU-REACH Registration No. – 01-2119532646-36-0000
1.3
SVHC.
We hereby certify that this product does not contain any Substance of Very High Concern
(SVHC) > 0.1% (w/w) listed on the most current Candidate list according to Art. 59 nor
listed on Annex XIV as published on the ECHA website
http:/echa.europa.eu/web/guest/candidate-list-table
2.
International Inventory Information
EINECS (EU)
In compliance
TSCA (USA)
In compliance
DSL (CDN)
In compliance
AICS (AUS)
In compliance
METI/ENCS/ISHL (J)
In compliance
ECL (KOR)
In compliance
PICCS (RP)
In compliance
IECSC (CN)
In compliance
HSNO (NZ)
In compliance
ECS (Taiwan)
In compliance
BAG (Switzerland)
In compliance
INSQ (Mexico)
In compliance
In compliance means: All components of the product are listed on the above mentioned
inventories or are exempted from listing, and are not being offered in violation of any rule
or order under their respective laws.
3.
Conformation for food and food contact
3.1
USA
The product does comply with the requirements of the US FDA as follows:
21 CFR 184.1619 (GRAS) Potassium carbonate – Food Additives and for Animal Feed
POTASSIUM CARBONATE and Solutions
FDA - EAFUS [Everything Added to Food in the United States] list updated 2013-April
21 CFR 163.111 Chocolate liquor – Food Additives
21 CFR 163.112 Breakfast cocoa (2006)
21 CFR 173.310 Boiler water additives - Food Additives
21 CFR 172.560 Modified hop extract
21 CFR 176.180 Paper/paperboard (dry food)
21 CFR 310.545. Drug products offered OTC for certain uses
21 CFR 310.545. Drug products containing certain active ingredients offered over-thecounter (OTC) for certain uses. (includes changes through 31 Mar 2009)
27 CFR 24.246 Materials authorized for the treatment of wine and juice
9 CFR 424.21 Use of food ingredients and sources of radiation. Subpart C-Food Ingredients
and Sources of Radiation
9 CFR 319.700 Margarine or oleomargarine. 64 FR 72175, Dec. 23, 1999
United States - 21 CFR 579. 40. Ionizing radiation for the treatment of poultry feed and
poultry feed ingredients
FCC – listed on Food Chemicals Codex, lastly on the 9th amendment
3.2
European Community / Declaration of Compliance (DoC)
The product is Potassium carbonate (CAS-No. 584-08-7) complies with the Regulation
(EC) No. 1935/2004 and Regulation (EU) 10/2011 as follows:
FCM substance No.: 21
Ref. No.: 42500
Substance name: Carbonic acid, salts (Art. 6 of Regulation (EU) 10/2011 applies for the
Potassium salt and therefore for Potassium carbonate, CAS-No. 584-08-7)
Use as additive or polymer production aid: Yes,
Use as monomer or other starting substance: No
FRF applicable: No
SML: Not applicable
SML(T): Not applicable
Restrictions and specifications: Not applicable
Notes for the verification of compliance: No restrictions or SML
Dual use Additive for use as Food additives according to regulations (EC) No.
1333/2008, (EC) No. 231/2012: Yes, E 501 (i)
Specifications: no restrictions for use in materials or articles
3.3
Germany Food / Food Contact statement
The product does fulfil the requirements of the German recommendations of the BfR
(Federal Institute for risk assessment) on contact with food:
BfR – XIV. Plastics Dispersions - •
5. pH regulator and polymerisation aids
BfR – XXI. Commodities based on Natural and Synthetic Rubber - • 2.1.3.2.2.4.5
Neutralising agents, pH- regulating substances
3.4
National Food / Food Contact statement / other Regulations
The product could be used as permitted Food Additive in the following countries:
Algeria, Argentina, Armenia, Australia, Austria, Bahrein, Belarus, Belgium, BosniaHerzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cuba, Curacao, Denmark,
Ecuador, Egypt, El Salvador, Eurasian Economic Union, Finland, France, Georgia, Germany,
Greece, Guatemala, Honduras, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan,
Kenya, Korea, Kosovo, Latvia, Luxembourg, Macau, Malaysia, Malta, Mauritius, Mexico,
Moldova, Morocco, Netherlands, New Zealand, Nicaragua, Nigeria, Palestine, Philippines,
Poland, Portugal, Qatar, Oman, Romania, Russia, Saudi Arabia, Singapore, Sint Maarten,
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South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine,
United Arab Emirates, United Kingdom, United States, Uzbekistan, Vietnam, Yemen
European Union (EU) listed as Food Additive on Regulation (EC) No 1333/2008 and
Regulation (EU) N° 231/2012 as E 501 (i)
Special regulations:
EU - Directive 2002/46/EC (Consolidated-2009-12-21): Food supplements, ANNEX II
Vitamin and mineral substances which may be used in the manufacture of
food supplements, B. Minerals, Potassium carbonate
Directive 91/321/EEC: Infant formulae and follow-on formulae
Brazil - Resolução RDC n° 46, de 19 de setembro de 2011: aditivos alimentares e
coadjuvantes de tecnologia para fórmulas infantis destinadas a lactentes e crianças de
primeira infância
GCC - GSO Standard No.: 354/1994 Infant foods based on milk, 4.23.3 pH adjusting agents
Qatar - GSO Standard No.: 354/1994 Infant foods based on milk, 4.23.3 pH adjusting
agents
Saudi Arabia - GSO Standard No.: 354/1994 Infant foods based on milk, 4.23.3 pH
adjusting agents
Turkey - Turkish Food Codex - Communication No 2008/52 consolidated with
attachments: Infant formulas [Turkish], 2. Mineraller as Potasyum karbonat
UN FAO - Codex General Standard for Food Additives (CODEX STAN 192-1995) Table 1
(Additive) and Table 3 (Acidity regulator)- Potassium carbonate, INS –No. 0501
FAO - Codex Stan 72 - 1981 Standard for Infant Formula and Formulas for Special Medical
Purposes Intended for Infants
Special national regulations:
German Cacao regulation - Par. 2 (6) use of potassium carbonate solution or substances
for neutralizations
German Tobacco regulation - Annex I, part A, No. 14b other additives
UK - PERMITTED ADDITIVES TO TOBACCO PRODUCTS IN THE UNITED KINGDOM, October
2003, Potassium carbonate - Additives with an inclusion limit at or above 0.15% of final
product, with an aggregated limit not exceeding 15% in cigarettes (less filter, plus
overwrap), RYO tobacco or cigars and 30% in pipe tobacco. (List 1)
Animal Feed / Feed materials:
EU - COMMISSION REGULATION (EU) No 575/2011 of 16 June 2011 on the Catalogue of
feed materials, 11. Minerals and products derived thereof, N° 11.5.3, Potassium carbonate,
Technical grade potassium carbonate (K2CO3), Compulsory declarations: Potassium, Ash
insoluble in HCl if > 10 %
COMMISSION REGULATION (EC) No 152/2009 of 27 January 2009 laying down the methods
of sampling and analysis for the official control of feed, E. DETERMINATION OF VOLATILE
NITROGENOUS BASES, 3. Reagents, Potassium carbonate
Belize - Fertilizers and Feeding Stuffs Regulations (S.I. No. 9 of 1979 as at 31 October
2003)
Printing Inks:
EuPIA European Printing Ink Association - Guidance: Inventory List Comprising Packaging
Ink Raw Materials Applied to the Non-Food Contact Surface of Food Packaging / version
December 2013
Switzerland - Food Contact Materials - 817.023.21 Verordnung des EDI vom 23. November
2005 über Bedarfsgegenstände (Stand am 1. April 2010)
- Anhang 6,Verpackungstinten part 1 (pp 1-66) - I. Liste der Bindemittel (Monomere) Teil
B. nicht evaluierte Stoffe Pg. 17
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Resolution of the Council of Europe (CoE):
Resolution AP (2002)1 on Paper and Boards - Potassium salts of alcohols
Resolution AP(2004)4: Rubber - Potassium salts of alcohols
Resolution AP(2004)3: Ion exchange -Potassium salts of alcohols
Resolution AP(2004)1: Coatings - Potassium salts of alcohols
Food Contact – Plastics (non-EU):
India - IS 10141:2001 Positive List of Constituents of Polyethylene in Contact with
Foodstuffs, Pharmaceuticals and Drinking Water (1-Nov-2001) (English) – 4.2
Manufacturing – Potassium carbonate less than 0.2 % by mass
Japan – Additives - Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA). SelfRestrictive Requirements on Food- Contacting Articles Made of Polyolefins and Certain
Polymers: Guidelines for Additives – G, Pg. 3 [1]
Mercosur - Plastics Additives
(Derogada) GMC/RES No 14/99 : Actualizacion lista positiva de aditivos para materiales
plásticos Pg. 3 [16]
GMC/RES N°50/01: Lista positiva de aditivos para plásticos Pg. 11 [16]
GMC/RES Nº 32/07: Lista Positiva de Aditivos para Materiales Plásticos destinados a la
Elaboración de Envases y Equipamientos en Contacto con Alimentos (1st) Pg. 22 [16]
GMC/RES Nº 32/07: Lista positiva de aditivos para materiais plásticos destinados à
elaboração de embalagens e equipamentos em contato com alimentos Pg. 28 [9]
Pharmacy Monographs:
German DAB 1999 - Kap. 4 – Reagent
USA - USP – NF38
EU - Pharmacopeia 8.0
Argentina - Farmacopea Argentina. 7º Edición. Volumen II - Monografías de Materia Prima
Brazil - Farmacopeia Brasileira. Volume 1. 5ª edição. 2010, Farmacopea Argentina. 7º
Edición. Volumen II - Monografías de Materia Prima
4.
Additional Regulations / Statements
4.1
Bisphenol-A-diglycidylether statement
We confirm that the product does not contain BADGE (Bisphenol-A-diglycidylether, CAS:
1675-54-3) in more than the omnipresent traces.
4.2
Alkylphenolethoxylate statement
We confirm that the product does not contain APEO (Alkylphenolethoxylate) in more than
the omnipresent traces.
4.3
CMR statement
The substance does not contain any CMR substances.
4.4
RoHS-directive 2011/65/EC, PAH and heavy metal statement
We confirm that the product fulfils the RoHS-regulation 2011/65/EC (replace 2002/95/EC,
the amendment 2008/35/EC inclusive decision of commission 2009/443/EC) and does
not contain neither the heavy metals Cd (100 ppm max), Pb (1000 ppm max), Hg (1000
ppm max), Cr+6 (1000 ppm max) nor the flame retardants PBB, PBDE, PCP,PFOS, TBTO or
plasticizers as DEHP, BBP, DBP, DIBP or any radioactive substances or arsenic, beryllium,
bismuth, nickel, selenium, thallium or formaldehyde in more than the omnipresent
traces.The restriction of DEHP, BBP and DBP shall not apply to toys which are already
subject to the restriction of DEHP, BBP and DBP through entry 51 of Annex XVII to
Regulation (EC) No 1907/2006.
Further we confirm that the product does not contain any polycyclic aromatic
hydrocarbons (PAH’s) in more than omnipresent traces.
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4.5
Kosher, Halal statement
Kosher status
We hereby certify that the product is manufactured by chemical process with mineral raw
materials. The product does not contain any ingredient of animal origin, any blood or
blood by-products or any alcohol. Alcohol has not been used in the manufacturing process.
The equipment used for manufacturing and packaging the above mentioned product is
not used for the manufacture and packaging of products of animal origin or products
containing animal or animal-derived ingredients.
Halal status
The product is non-Haram (minimum requirement) and is Halal using Codex Alimentarius
Guidelines.
This means that the product we supply you with is:
1.
Free from animal origin, alcohol an genetic modified products (as defined by Halal
terms as defined in CAC/GL 24/1997) and there is not any cross contaminations with
Haram products,
2.
Halal as defined in the Codex general guideline CAC/GL 24-1997 with the
exception on labelling
4.6
Genetically Modified Organisms statement
The product has not been manufactured by using intentionally any products of animal or
vegetable or GMO (Genetically Modified Organisms) origin.
4.7
Nano statement
The product does not consists of any nano-materials as defined by the European
Commission. Registrations according to national laws are not required.
4.8
Biocides statement
The product does not contain any biocidal active substance.
4.9
Ozone depleting chemicals statement
The product does not contain any ozone depleting substances according to the Montreal
Protocol.
4.10
TSE/BSE statement
We confirm that the product is produced solely from synthetic raw material only, and no
material used in the manufacture is of bovine or any animal origin.
In addition, we confirm that no material of animal origin is present at any time during
production or is used for production in the same plant.
Therefore, with regard to the conditions of our production process and the raw materials
used, the BSE/TSE risk is, according to our knowledge, not to be seen as relevant.
4.11
Cosmetics / Allergens statement
EU - The product is listed with INCI name POTASSIUM CARBONATE as cosmetic ingredient
for BUFFERING list on EU Cosmetics Ingredients Inventory, no restrictions.
Chile - Decreto Nº 239/02: Listado de Ingredientes Permitidos en Productos Cosméticos
China - Standard Chinese Name Catalogue of International Cosmetic Ingredients (Dec 14
2010) (English) and Directory for Cosmetic Ingredients (CFDA 11 2014)
Peru - Resolución Directoral N° 152-2012: Se aprueba el Listado de Excipientes as
CARBONATO DE POTASIO
Japan - JSCI – Japanese Standard of Cosmetic Ingredients – not listed
CTFA – Cosmetic, Toiletry and Fragance Association – not listed
IFRA – International Fragance Association – not listed
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POTASSIUM CARBONATE and Solutions
We hereby confirm that the product is neither listed on Annex II of Regulation (EC) No.
1223/2009 and amendments nor on any other annexes of this regulation.
The product does not contain any allergens according to Annex III of Regulation (EC ) No.
1223/2009,
List of 26 “allergens” according to Regulation (EC) No.
1223/2009, Annex III
2-METHYL-3-(4-(1,1-DIMETHYL ETHYL) PHENYL)
PROPANAL (LILIAL)
ALPHA METHYL IONONE
AMYL CINNAMIC ALCOHOL
AMYL CINNAMIC ALDEHYDE
ANISYL ALCOHOL
BENZYL ALCOHOL
BENZYL BENZOATE
BENZYL CINNAMATE
BENZYL SALICYLATE
CINNAMIC ALCOHOL
CINNAMIC ALDEHYDE
CITRAL
CITRONELLOL
COUMARIN
EUGENOL
FARNESOL
GERANIOL
HEXYLCINNAMIC ALDEHYDE
HYDROXYCITRONELLAL
HYDROXYMETHYLPENTTYLCYCLOHEXENE
CARBOXALDEHYDE (LIRAL)
ISOEUGENOL
LIMONENE
LINALOOL
METHYL HEPTINE CARBONATE
OAKMOSS
TREEMOSS
CAS-No.
80-54-6
127-51-5
101-85-9
122-40-7
105-13-5
100-51-6
120-51-4
103-41-3
118-58-1
104-54-1
104-55-2
5392-40-5
106-22-9
91-64-5
97-53-0
4602-84-0
106-24-1
101-86-0
107-75-5
31906-04-4
97-54-1
5989-27-5
78-70-6
111-12-6
90028-68-5
90028-67-4
4.12
Declaration of non-animal or non-cell-culture origin statement
(USDA declaration)
The product, is chemically synthesized and it does not contain any animal or cell culture
derived products. The product is not derived from any animal or cell culture derived
products.
4.13
Glutens, Aflatoxins, Mycotoxins, Melamine and Latex statement
The product and associated packaging are free of glutens, aflatoxins, mycotoxins,
melamine and latex.
4.14
Metal Catalysts, Reagents and Heavy metals statement
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The product does not contain any metal catalysts and/or metal reagents according to the
guideline on the specification limits for residues of metal catalysts or metal reagents,
Ref. No. EMEA/CHMPS/SWP/4446/2000.
Based on manufacturing process not exceeded in the final product.
The product manufactured by Evonik Degussa GmbH, Lülsdorf, meets the requirements
fixed in the regulation (EU) N° 231/2012 with concern to the impurity levels.
Heavy metals content to the regulation (EU) N° 231/2012:
The specified limits are:
•
Arsenic
•
Lead
•
Mercury
4.15
not more than 3 ppm
not more than 2 ppm
not more than 1 ppm
Residual Solvents statement
For the product the following solvents are used or to be present with the given amount
in accordance with the Guideline for Residual Solvents (CPMP/ICH/283/95):
No residual solvents present.
4.16
Jatropha Plant statement
For the manufacture of the product only synthetic raw materials are used in the
production facilities in Germany.
4.17
Benzene statement
Benzene is not used in the manufacturing process of the product and therefore it does
not contain any benzene.
4.18
Toy´s Directive / EN 71-3 statement
The product, its raw materials or all other materials used in the manufacturing process
of the product are in accordance with Toy´s Directive 2009/48/EC as well as EN 71-3
includes all amendments and does not contain the following substances above the
therein mentioned levels:
Lead, Mercury, Cadmium, Chromium (VI)
4.19
Phthalate statement
To the best of our knowledge the product, its raw materials or all other materials used in
the manufacturing process of the product do not contain the following substances
Diisobutyl phthalate (DIBP)
Dibutyl phthalate (DBP)
Bis(2-ethylhexyl)phthalate(DEHP)
Dihexyl phthalate (DHP)
Dicyclohexyl phthalate (DCHP)
CAS-No. 84-69-5
CAS-No. 84-74-2
CAS-No. 117-81-7
CAS-No. 84-75-3
CAS-No. 84-61-7
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The substances are not added during the synthesis steps. A formation during synthesis
is unlikely. However, we want to point out that the product is not tested in respect to the
mentioned substances.
4.20
Ionising Radiation / Irradiation / ETO statement
The product is not treated by ionising radiation. Legal reference: Directive 1999/2/EC
dated 22 February 1999 on the approximation of the laws of the Member States
concerning foods and food ingredients treated with ionising radiation.
The product is not sterilized by using irradiation or treated with Ethylene oxide (EO) at
any point of our manufacturing process.
4.21
Conflict Mineral Sources statement (US Dodd-Frank Act)
Evonik Performance Materials GmbH is not a publicly-traded company in the United
States and therefore not required to comply with US Dodd-Frank Act’s conflict minerals
provisions. However, many of our customers are publicly traded in the United States and
subject to this law. In order to assist our customers, we are voluntarily attempting to
determine the use and source of any metals intentionally added to our products, or used
in the manufacture of our products, which are designated as “conflict minerals” by the
Dodd-Frank Act.
Products distributed by Evonik Performance Materials GmbH may contain the above
mentioned metals, even though we don’t purchase these metals directly from smelters or
mines. In conducting origin inquiries of these substances we have to rely on adequate
information provided by our suppliers. We are verifying the given information with due
diligence and adopting necessary measures to clarify the origin of any metals in a
comprehensive manner. In the framework of a responsible and sustainable supply chain
we expect our suppliers to do the same.
As a result of our reasonable country of origin inquiry Evonik Performance Materials GmbH
has to date no reason to believe that our products was intentionally manufactured with or
uses “conflict minerals” (as defined by the US Dodd-Frank Act).
Evonik Performance Materials GmbH recognizes the importance of corporate responsibility
and the need to meet the prevailing requirements as a reliable and responsible business
partner. In this regard, the Evonik Groups’s annual Corporate Responsibility/Sustainability
Report sets forth our responsibility/sustainability policies, strategy, and plans for
implementation.
If you would like additional information on Evonik Group’s responsibility/sustainability
policies and strategy, the Evonik Group Code of Conduct or other policies, please visit the
following link: http://evonik.com/responsibility.
4.22
Animal or human derived materials statement
We confirm that the product does not contain any animal or human derived materials.
4.23
Asbestos / Dioxins statement
The product and starting raw materials as well as associated packaging, does NOT contain
any asbestos or dioxins
4.24
HACCP statement
We confirm to our customer that we established quality assurance system and the product
mentioned above fulfill the requirements of the quality assurance system in view of health
safety of product according to HACCP is implemented
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POTASSIUM CARBONATE and Solutions
4.25
Pesticides and herbicides statement
The product and starting raw materials as well as associated packaging, does NOT contain
any pesticides and herbicides
Remark: Chlorine is produced
Disclaimer:
All information given in this Regulatory Information/Declaration of Compliance are based
on our present knowledge and experience. All information are intended for persons having
the required skill and know-how and do not relieve you from verifying the suitability of the
information given for a specific purpose prior to use by testing, which should be carried
out only by qualified experts. Use or application of such information is at your sole
responsibility and risk, without any liability on the part of Evonik Performance Materials
GmbH. We reserve the right to make any changes required by law or as necessitated by
new knowledge.
Further information could be found on our Material Safety Data Sheet (SDS):
Hazards identification, REACH-Registration number (if already available), First Aid,
Fire Fighting Measures, Accidental release measures, Handling and Storage,
Exposure Control, Personal Protection, Physical and Chemical Properties, Stability
and Reactivity, Toxicological and Ecological Information, Disposal Considerations,
Risk Information (e.g. Transportation, Labeling, Risk Phrases, Water Hazard Class,
International Registration Status.
Please, pay attention to the national edition of the SDS.
The following e-mail address should be used in order to request the SDS:
[email protected]
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